Relationship Between Eslicarbazepine Exposure and Efficacy of Eslicarbazepine Acetate Adjunctive Therapy

Authors: Harvey JH, Andermann E, Chung S, Trinka E, Cendes F, Passarell JA, Fiedler-Kelly J, Ludwig EA, Sunkaraneni S, Sousa R, Rocha F, Blum D
Conference: American Epilepsy Society (AES)
Keywords: AED, epilepsy, eslicarbazepine, eslicarbazepine acetate, neurology, PK, pkpd
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Introduction

  • Eslicarbazepine acetate (ESL; Aptiom®) is a novel once-daily (QD) oral antiepileptic drug, approved in the
    US, Canada and the EU as adjunctive treatment of partial-onset seizures (POS).
  • ESL is extensively and rapidly converted to eslicarbazepine after oral administration.1
  • Data from three randomized, controlled, Phase III trials (Studies 301, 302, and 304) demonstrated that
    ESL was effective as adjunctive therapy for POS.2

    • ESL led to dose-related improvements in most efficacy outcomes, with an effective dose range of
      800–1200 mg QD.
  • Data from the above studies were used to examine the relationship between eslicarbazepine exposure
    and selected efficacy endpoints.

Poster originally presented at: American Epilepsy Society (AES) Annual Meeting: December 5-9, 2014, Seattle, WA. Encore presented at: American Conference on Pharmacometrics (ACoP) Annual Meeting: October 4-7, 2015, Crystal City, VA.

By Jay H Harvey, Eva Andermann, Steve Chung, Eugen Trinka, Fernando Cendes, Julie A Passarell, Jill Fiedler-Kelly, Elizabeth A Ludwig, Soujanya Sunkaraneni, Rui Sousa, Francisco Rocha, David Blum